Wednesday, September 21, 2011

General Requirements
For moderately and highly complex tests, the laboratory must:
􀁺 Follow the manufacturer's instructions.
􀁺 Have a procedure manual describing the process of the tests
and reporting patient test results.
􀁺 Perform and document calibration procedures or check
calibration at least once every six months.
􀁺 Perform and document control procedures using at least two levels of controls each day of testing.
􀁺 Perform and document applicable specialty and subspecialty control procedures.
􀁺 Perform and document remedial action taken when problems or errors are identified.
􀁺 Maintain records of all quality control activities for two years (five years for immunohematology).
Facilities
The laboratory must have space and environmental conditions necessary for conducting the services offered. This includes being constructed, arranged and maintained to ensure the space, ventilation and utilities necessary for conducting all phases of testing.
Safety precautions must be established, posted and observed to ensure protection from physical, chemical, biochemical and electrical hazards and biohazardous materials.
Test Methods, Equipment, Instruments, Reagents, Materials and Supplies
The laboratory must utilize test methods, equipment, instruments, reagents, materials and supplies that provide accurate and reliable test results and reports.
Requirements include
-Utilize appropriate and sufficient equipment, instruments, reagents, materials and supplies for the type and volume of testing performed and for the assurance of quality throughout the testing; and, test result reporting, including (as applicable): -Selecting methodologies and equipment and performing testing in a manner that provides test results within the laboratory's stated performance specifications for each method
-Water quality
-Temperature
-Humidity
-Protection of equipment and instrumentation from fluctuations and interruptions in electrical current that adversely affect results and reports
Document remedial actions implemented to correct conditions that fail to meet criteria
-Label reagents, solutions, culture media, control materials, calibration materials and other supplies including identification for:
Storage requirements-
-Identity, and when pertinent, titer, strength or concentration
-Preparation and expiration date Other appropriate information
-Prepare, store and handle reagents, solutions, culture media, control materials, calibration materials and other supplies in a manner to ensure:
- Items are not used when they have exceeded their expiration date, have deteriorated or are of sub-standard quality.
-Components of reagent kits of different lot numbers are not interchanged unless otherwise specified by the manufacturer
Control procedures
Remedial action to be taken when calibration or control results fail to meet the laboratory's criteria for acceptability.
-Limitations in methodologies, including interfering substances
Reference or normal ranges
-Imminent life-threatening laboratory results or panic (critical values. Must be informed at once by telephone to doctor e.g. Meningococci in direct gram of CSF.
-Pertinent literature references
Appropriate criteria for specimen storage and preservation to ensure specimen integrity until testing is completed.
The laboratory's system for reporting patient results including, when appropriate, the protocol for reporting panic values. Description of the steps to be taken in the event that a test system becomes inoperable. Criteria for the referral of specimens including procedures for specimen submission and handling
You can find more in book entiteled Lectures on applied clinical microbiology